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临床试验/NCT04735211
NCT04735211Unknown不适用

Risk Factors to Develop Chronic Postsurgical Pediatric Pain: An Observational Study

Guillermo Ceniza Bordallo1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2020年12月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
260
试验地点
1
主要终点
Type of surgery

研究概览

简要总结

Chronic postsurgical pain had number of prevalence on 20%. Its derivates from risk factors, but recent research provide new potential risk factors to develop chronic postsurgical pediatric pain.

To increase the body of knowledge, an observational study is proposed in pediatric patients undergoing surgical intervention.

详细描述

A cohort of pediatric patients undergoing surgery will be followed at the Maternal and Child Hospital October 12, Madrid. The group of patients that develops post-surgical chronic pain and the group that does not develop it will be observed, and risk factors will be studied.

Before the surgical intervention, the risk factors described in the literature will be analyzed. Children will be followed up to 6 months after surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children with age from 4 years to 18 years. Undergoing surgery for any surgical specialty. ASA Status (American Society of Anesthesiologist) from I to III.

排除标准

  • Children who do not understand and speak Spanish correctly. Children with verbal communication problems.

结局指标

主要结局

Type of surgery

时间窗: 1 day presurgery

Surgery Specialty.

Previous pathologies

时间窗: 1 day presurgery

Previous pathologies

Baseline Child Catastrophizing

时间窗: 1 day presurgery

Assess by Child Catastrophizing scale.The Pain Catastrophizing Scale-Child (PCS-C);is a validated self-report measure that is used to assess negative thinking associated with pain. The PCS-C include 13 items, which are rated on a 5-point scale ranging from 0 = "not at all true" to 4 = "very true." The items are divided across three subscales: rumination (4 items, e.g. "When I have pain, I can't keep it out of my mind"), magnification (3 items, e.g. "When I have pain, I keep thinking of other painful events") and helplessness (6 items, e.g. "When I have pain, I feel like I can't go on"

Change of Child Catastrophizing at 3 moths postsurgery

时间窗: 3 months

Assess by Child Catastrophizing scale.The Pain Catastrophizing Scale-Child (PCS-C);is a validated self-report measure that is used to assess negative thinking associated with pain. The PCS-C include 13 items, which are rated on a 5-point scale ranging from 0 = "not at all true" to 4 = "very true." The items are divided across three subscales: rumination (4 items, e.g. "When I have pain, I can't keep it out of my mind"), magnification (3 items, e.g. "When I have pain, I keep thinking of other painful events") and helplessness (6 items, e.g. "When I have pain, I feel like I can't go on"

Change of Child Catastrophizing at 6 moths postsurgery

时间窗: 6 months

Assess by Child Catastrophizing scale.The Pain Catastrophizing Scale-Child (PCS-C);is a validated self-report measure that is used to assess negative thinking associated with pain. The PCS-C include 13 items, which are rated on a 5-point scale ranging from 0 = "not at all true" to 4 = "very true." The items are divided across three subscales: rumination (4 items, e.g. "When I have pain, I can't keep it out of my mind"), magnification (3 items, e.g. "When I have pain, I keep thinking of other painful events") and helplessness (6 items, e.g. "When I have pain, I feel like I can't go on"

Baseline Child Anxiety

时间窗: 1 day presurgery

Assess by Child Anxiety Symptoms Scale (CPASS) is a 20-item scale for children adapted from the adult PASS-20. For each statement, children are asked to rate the extent to which they think, act, or feel that way on a scale from 0 (''never think, act or feel that way'') to 5 (''always think, act, or feel that way''). Total scores range from 0 to 100, with higher scores indicating higher levels of pain anxiety.

Change of Child Anxiety at 3 moths postsurgery

时间窗: 3 moths

Assess by Child Anxiety Symptoms Scale (CPASS) is a 20-item scale for children adapted from the adult PASS-20. For each statement, children are asked to rate the extent to which they think, act, or feel that way on a scale from 0 (''never think, act or feel that way'') to 5 (''always think, act, or feel that way''). Total scores range from 0 to 100, with higher scores indicating higher levels of pain anxiety.

Change of Child Anxiety at 6 moths postsurgery

时间窗: 6 moths

Assess by Child Anxiety Symptoms Scale (CPASS) is a 20-item scale for children adapted from the adult PASS-20. For each statement, children are asked to rate the extent to which they think, act, or feel that way on a scale from 0 (''never think, act or feel that way'') to 5 (''always think, act, or feel that way''). Total scores range from 0 to 100, with higher scores indicating higher levels of pain anxiety.

Baseline Pain Interference

时间窗: 1 day presurgery

Asess by PROMIS-Pediatric Pain Interference Scale (PPIS): The 8-item PPIS assesses how the child's pain has interfered with certain aspects of their life over the past 7 days (eg, sleep, attention, schoolwork, physical activities, emotion). Each item is rated on a 5-point scale ranging from "never" to "almost always". Scores range from 0 to 32 where higher scores indicate greater pain-related functional impairment.

Change of Pain Interference at 3 moths postsurgery

时间窗: 3 moths

Asess by PROMIS-Pediatric Pain Interference Scale (PPIS): The 8-item PPIS assesses how the child's pain has interfered with certain aspects of their life over the past 7 days (eg, sleep, attention, schoolwork, physical activities, emotion). Each item is rated on a 5-point scale ranging from "never" to "almost always". Scores range from 0 to 32 where higher scores indicate greater pain-related functional impairment.

Change of Pain Interference at 6 moths postsurgery

时间窗: 6 moths

Asess by PROMIS-Pediatric Pain Interference Scale (PPIS): The 8-item PPIS assesses how the child's pain has interfered with certain aspects of their life over the past 7 days (eg, sleep, attention, schoolwork, physical activities, emotion). Each item is rated on a 5-point scale ranging from "never" to "almost always". Scores range from 0 to 32 where higher scores indicate greater pain-related functional impairment.

Baseline Child Fear of pain

时间窗: 1 day presurgery

Assess by The Fear of Pain Questionnaire-Children (FOPQ-C): Is a validated self-report measure that used to asses fear of pain in children. The FOPQ-C include 23 ítems, which are rated on a 5-point scale ranging 0=" not at all" 5="very true". The items are divided across two subscales: fear of pain, and avoidance activities.

Change of Child Fear of pain at 3 moths postsurgery

时间窗: 3 moths

Assess by The Fear of Pain Questionnaire-Children (FOPQ-C): Is a validated self-report measure that used to asses fear of pain in children. The FOPQ-C include 23 ítems, which are rated on a 5-point scale ranging 0=" not at all" 5="very true". The items are divided across two subscales: fear of pain, and avoidance activities.

Change of Child Fear of pain at 6 moths postsurgery

时间窗: 6 moths

Assess by The Fear of Pain Questionnaire-Children (FOPQ-C): Is a validated self-report measure that used to asses fear of pain in children. The FOPQ-C include 23 ítems, which are rated on a 5-point scale ranging 0=" not at all" 5="very true". The items are divided across two subscales: fear of pain, and avoidance activities.

Baseline Child Kinesiophobia

时间窗: 1 day presurgery

Assess by The Tampa Scale Kinesiophobia (TSK-11). Is a 11-item scale that measures fear of move- ment-evoked pain and injury. Scale items ranges from 0 (strongly disagree) to 4 (strongly agree) with 4 reversed- scored items. Total scores range from 25 to 56 with higher scores indicative of a greater fear of movement.

Change of Child Kinesiophobia at 3 moths postsurgery

时间窗: 3 moths

Assess by The Tampa Scale Kinesiophobia (TSK-11). Is a 11-item scale that measures fear of move- ment-evoked pain and injury. Scale items ranges from 0 (strongly disagree) to 4 (strongly agree) with 4 reversed- scored items. Total scores range from 25 to 56 with higher scores indicative of a greater fear of movement.

Change of Child Kinesiophobia at 6 moths postsurgery

时间窗: 6 moths

Assess by The Tampa Scale Kinesiophobia (TSK-11). Is a 11-item scale that measures fear of move- ment-evoked pain and injury. Scale items ranges from 0 (strongly disagree) to 4 (strongly agree) with 4 reversed- scored items. Total scores range from 25 to 56 with higher scores indicative of a greater fear of movement.

Baseline Health-related Quality of Life in Children

时间窗: 1 day presurgery

Pediatric Quality of Life version 4.0 (PedsQL 4.0), which is a widely used measure of health-related quality of life in children. The PedsQL consists of 23-items and includes both child-report (for those age 8 and over). The PedsQL assesses the following four domains of functioning: physical, emotional, social, and school and items are rated on a five-point Likert-type scale that ranges from 0 (never a problem) to 4 (almost always a problem). Items are converted to create a 0-100 scale, with higher scores reflecting higher quality of life.

Change of Health-related Quality of Life in Children at 3 moths postsurgery

时间窗: 3 moths

Pediatric Quality of Life version 4.0 (PedsQL 4.0), which is a widely used measure of health-related quality of life in children. The PedsQL consists of 23-items and includes both child-report (for those age 8 and over). The PedsQL assesses the following four domains of functioning: physical, emotional, social, and school and items are rated on a five-point Likert-type scale that ranges from 0 (never a problem) to 4 (almost always a problem). Items are converted to create a 0-100 scale, with higher scores reflecting higher quality of life.

Change Health-related Quality of Life in Children at 6 moths postsurgery

时间窗: 6 moths

Pediatric Quality of Life version 4.0 (PedsQL 4.0), which is a widely used measure of health-related quality of life in children. The PedsQL consists of 23-items and includes both child-report (for those age 8 and over). The PedsQL assesses the following four domains of functioning: physical, emotional, social, and school and items are rated on a five-point Likert-type scale that ranges from 0 (never a problem) to 4 (almost always a problem). Items are converted to create a 0-100 scale, with higher scores reflecting higher quality of life.

Baseline Pain intensity

时间窗: 1 day presurgery

Assess by The Numerical Rating Scale (NRS) is a verbally administered scale that measures pain intensity (''how much pain do you feel right now?''). The NRS can also be used to measure pain unpleas- antness (''how unpleasant/horrible/yucky is the pain right now?''). The end points represent the extremes of the pain experience.

Change of Pain intensity 3 moths postsurgery

时间窗: 3 moths

Assess by The Numerical Rating Scale (NRS) is a verbally administered scale that measures pain intensity (''how much pain do you feel right now?''). The NRS can also be used to measure pain unpleas- antness (''how unpleasant/horrible/yucky is the pain right now?''). The end points represent the extremes of the pain experience.

Change of Pain intensity at 6 moths postsurgery

时间窗: 6 moths

Assess by The Numerical Rating Scale (NRS) is a verbally administered scale that measures pain intensity (''how much pain do you feel right now?''). The NRS can also be used to measure pain unpleas- antness (''how unpleasant/horrible/yucky is the pain right now?''). The end points represent the extremes of the pain experience.

次要结局

  • Baseline Parent Anxiety(1 day presurgery)
  • Change of Parent Anxiety at 3 moths postsurgery(3 moths)
  • Change of Parent Anxiety at 6 moths postsurgery(6 moths)
  • Baseline Parent Catastrophizing(1 day presurgery)
  • Change of Parent Catastrophizing at 3 months postsurgery(3 moths)
  • Change of Parent Catastrophizing at 6 months postsurgery(6 moths)
  • Baseline Parent Fear of pain(1 day presurgery)
  • Change of Parent Fear of pain at 3 moths postsurgery(3 moths)
  • Change of Parent Fear of pain at 6 moths postsurgery(6 moths)
  • Baseline Parent Kinesiophobia(1 day presurgery)
  • Change of Parent Kinesiophobia at 3 moths postsurgery(3 moths)
  • Change of Parent Kinesiophobia at 6 moths postsurgery(Baseline, 3 moths, 6 months)
  • Change of Pain intensity assess by parents at 3 moths postsurgery(3 moths)
  • Baseline Health-related Quality of life in children(1 day presurgery)
  • Change of Health-related Quality of life in children at 3 moths postsurgery(3 moths)
  • Change of Health-related Quality of life in children at 6 moths postsurgery(6 months)
  • Baseline Pain intensity assess by parents(1 day presurgery)
  • Change of Pain intensity assess by parents at 6 moths postsurgery(6 months)

研究者

发起方
Guillermo Ceniza Bordallo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guillermo Ceniza Bordallo

Principal Investigator

Universidad Complutense de Madrid

研究点 (1)

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